- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351435
The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique
Study Overview
Status
Detailed Description
In the Caribbean region, access to advanced cardiac interventions faces difficulties owing to unequal distribution of health care resources, medical shortages and distance between health care centers in various islands.
At the University Hospital of Martinique (UHM) in Fort de France, a mobile ECMO team is available 24h a day, 7 days a week, for cardiopulmonary mechanical support in the French Overseas Territories and neighboring islands.
Implantation of veno-venous or veno-arterial (VV or VA) ECMO can be performed at the UHM or at remote hospitals. Some patients on VA-ECMO are transfered by airflight to the UHM and/or to French mainland whenever cardiac transplantation is indicated.
Since 2010, the ECMO-UHM database is a prospective event-driven registry housed and updated by the HeartTeam (perfusionnists, emergency and ICU physicians, cardiac surgeons, cardiothoracic anesthesiologists, cardiologists).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marc LICKER, MD
- Phone Number: +41796234488
- Email: marc.licker@unige.ch
Study Contact Backup
- Name: Jeremy MAZILE, BC perfusionnist
- Email: jermy.bazile@chu-martinique.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All consecutive patients implanted with a veno-venous extracorporeal membrane oxygenation device or extracorporeal membrane oxygenation device by the HeartTeam from the University Hospital of Martinique (UHM) from January 2010
Exclusion Criteria:
- Patients with incomplete data (primary endpoint and less than 80% secondary study outcomes)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
VV-ECMO
Patients with respiratory failure
|
|
VA-ECMO
Patients with cardiac failure or combined cardiopulmonary failure
|
|
VAV-ECMO
Patients initially on VV or VA-ECMO who require additional respiratory/circulatory support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality at 30 days
Time Frame: from canula implantation to 30 days afterwards
|
Number of deceased participants as assessed at 30 days after ECMO implantation
|
from canula implantation to 30 days afterwards
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with major adverse events
Time Frame: From canula implantation to up to 6 months after ECMO implantation
|
Major Adverse events (AE; numbers and rates) as assessed by the consensus statement of the mechanical circulatory support academic research consortium
|
From canula implantation to up to 6 months after ECMO implantation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marc LICKER, BC, CHU Martinique
Publications and helpful links
General Publications
- Serpa Neto A, Higgins AM, Bailey MJ, Anderson S, Bernard S, Fulcher BJ, Jones A, Linke NJ, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Dicker C, Reddi BAJ, Stub D, Trapani TV, Udy AA, Hodgson CL; EXCEL Study Investigators on behalf of the International ECMO Network (ECMONet). Long-Term Functional Outcomes in the First 12 Months After VA-ECMO in Adult Patients: A Prospective, Multicenter Study. Circ Heart Fail. 2025 Jun;18(6):e012476. doi: 10.1161/CIRCHEARTFAILURE.124.012476. Epub 2025 Apr 29.
- Ling RR, Chen Y, Low CJW, Agerstrand C, Jung JS, Lim SL, Lorusso R, Mueller T, Okada Y, Tonna JE, Shekar K, Brodie D, MacLaren G, Ramanathan K. Left ventricular unloading during extracorporeal cardiopulmonary resuscitation: a target trial emulation of the ELSO registry. Crit Care. 2025 May 8;29(1):186. doi: 10.1186/s13054-025-05345-3.
- Grazioli A, Plazak M, Willsey K, Rabin J, Rector RP, Belyayev L, Lankford AS, Scalea TM, Shah A, Taylor BS, Gladwin MT. Outcomes and survival prediction in adults with sickle cell disease treated with extracorporeal membrane oxygenation. Blood Adv. 2025 Oct 14;9(19):4881-4890. doi: 10.1182/bloodadvances.2025016368.
- Labrada L, Alarfaj M, Tran L, Granger H, Hernandez A, Hu J, Baker J, Grandin EW, Delgado AA, Katz JN, Miller PE, Alviar CL, Osborn E, Bacchetta MD, Lindenfeld J, Shah Z, Rali AS. Optimal ECLS Support in Mixed Cardiogenic and Septic Shock: An ELSO Registry Analysis. JACC Adv. 2025 Oct;4(10 Pt 1):101965. doi: 10.1016/j.jacadv.2025.101965. Epub 2025 Jul 23.
- Wang L, Wang K, Wang Y, Yang F, Li C, Hao X, Du Z, Rycus PT, Tonna JE, Fan E, Wang H, Hou X. A simple VA-ECMO bundle in adult patients with cardiogenic shock: an analysis of ELSO registry. EClinicalMedicine. 2025 Aug 7;87:103423. doi: 10.1016/j.eclinm.2025.103423. eCollection 2025 Sep.
- Baldetti L, Pontillo D, Capoccia M, Kowalewski M, Tonna JE, Broman M, Conrad SA, Swol J, Scandroglio AM, Brewer JM, Maybauer MO, Lorusso R. VENOPULMONARY EXTRACORPOREAL LIFE SUPPORT: AN ELSO REGISTRY ANALYSIS. J Heart Lung Transplant. 2026 Jan 6:S1053-2498(25)02480-5. doi: 10.1016/j.healun.2025.12.024. Online ahead of print.
- Moynihan KM, Sharma M, Mehta A, Lillie J, Ziegenfuss M, Festa M, Chan T, Thiagarajan R. Race-Conscious Research Using Extracorporeal Life Support Organization Registry Data: A Narrative Review. ASAIO J. 2024 Sep 1;70(9):721-733. doi: 10.1097/MAT.0000000000002206. Epub 2024 Apr 18.
- Remy T, Jegard J, Chenouard A, Maminirina P, Liet JM, Couec ML, Joram N, Bourgoin P. Characteristics and outcomes of children and young adults with sickle cell disease supported with extracorporeal membrane oxygenation (ECMO): An updated analysis of the ELSO registry. Artif Organs. 2025 Mar;49(3):508-515. doi: 10.1111/aor.14880. Epub 2024 Oct 3.
- Mazzeffi M, Zaaqoq A, Curley J, Buchner J, Wu I, Beller J, Teman N, Glance L. Survival After Extracorporeal Cardiopulmonary Resuscitation Based on In-Hospital Cardiac Arrest and Cannulation Location: An Analysis of the Extracorporeal Life Support Organization Registry. Crit Care Med. 2024 Dec 1;52(12):1906-1917. doi: 10.1097/CCM.0000000000006439. Epub 2024 Oct 9.
- Kanwar MK, Shah P, Cascino T, Grinstein J, Goldstein D, Hernandez-Montfort J, Li S, Uriel N, Molina E, Cantor R, Komanduri B, Pagani FD, Kirklin JK. Impact of Preoperative Temporary Mechanical Circulatory Support on Durable LVAD Outcomes: An Analysis of The Society of Thoracic Surgeons National Intermacs Database. JACC Heart Fail. 2025 Nov;13(11):102671. doi: 10.1016/j.jchf.2025.102671. Epub 2025 Oct 8.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Genetic Diseases, Inborn
- Infections
- Respiratory Tract Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Lung Diseases
- Respiration Disorders
- Infarction
- Necrosis
- Hematologic Diseases
- Embolism and Thrombosis
- Embolism
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Anemia
- Hemoglobinopathies
- Myocardial Ischemia
- Myocardial Infarction
- Shock
- Lung Injury
- Anemia, Sickle Cell
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Ischemia
- Respiratory Insufficiency
- Pulmonary Embolism
- Sepsis
- Heart Arrest
- Shock, Cardiogenic
- Acute Lung Injury
- Sickle Cell Trait
Other Study ID Numbers
- 18-11-2025 CHUM CVT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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